Mobile sterilization apparatus and method for using the same

ABSTRACT

A sterilization cabinet, comprising a top panel, at least two side panels, and a floor panel forming a part of a chamber of the sterilization cabinet; at least one door connected to at least one of the at least two side panels of the sterilization cabinet; a vent formed in at least one of the two side panels; at least one first filter covering the vent and a filter cover configured to hold the first filter against the vent; a drain positioned in the floor panel, wherein the floor panel has a slope configured to cause condensate within the chamber to flow into the drain and wherein the drain is the only outlet for the condensate along the floor panel; and a second filter covering the drain such that condensate flowing into the drain passes through the second filter.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.16/519,600, filed Jul. 23, 2019, now U.S. Pat. No. 10,786,589, which isa continuation of U.S. patent application Ser. No. 16/119,726, filedAug. 31, 2018, now U.S. Pat. No. 10,413,628, which is a continuation ofU.S. patent application Ser. No. 15/663,230, filed Jul. 28, 2017, nowU.S. Pat. No. 10,086,100, which is related to U.S. patent applicationSer. No. 15/369,713 filed Dec. 5, 2016, now U.S. Pat. No. 9,833,524,which is a continuation of U.S. patent application Ser. No. 14/644,094,filed Mar. 10, 2015, now U.S. Pat. No. 9,808,545, which claims thebenefit of U.S. Provisional Application Nos. 61/950,502, filed Mar. 10,2014 and 62/053,338, filed Sep. 22, 2014, the contents of which areincorporated herein by reference in their entireties.

FIELD OF THE TECHNOLOGY

This invention relates to medical devices and procedures in general, andmore particularly to sterilization apparatus and procedures forsterilizing medical instruments and/or devices and maintaining sterilityuntil their intended use.

BACKGROUND

Many medical procedures require the use of sterile instruments and/ordevices to perform the medical procedure. Providing sterile instrumentsand/or devices for these medical procedures is currently atime-consuming and expensive undertaking that requires, among otherthings, many man-hours, specialized equipment, etc.

In the past, hospitals (and/or other surgical facilities, e.g.,surgicenters, etc.) have used an instrument tray sterilization system,in which trays containing the required instruments and/or devices for agiven procedure are wrapped with a specially manufactured disposablewrap. The wrapped trays are then autoclaved and processed to themanufacturers' recommendations. The trays are then removed from theautoclave, allowed to cool, and then stored until the contents areneeded for a procedure. Prior to the use of the instruments and/ordevices, additional man-hours are expended to inspect the wraps so as toensure that there is no damage that might lead to the contents beingdeemed non-sterile.

In part to address some of the shortcomings discussed above, mobilesterilization cabinets have been introduced. FIGS. 1-3 show an exemplaryprior art mobile sterilization cabinet 5. Sterilization cabinet 5typically comprises a rectangular-shaped interior chamber 10 (FIG. 2)surrounded by a cabinet bottom 25, cabinet side walls 26, a cabinet backwall 27 and a cabinet top 40. Cabinet 5 may further comprise one or moredoors 30 to selectively open up or close off interior chamber 10 ofcabinet 5. See, for example, FIG. 2 which shows a cabinet 5 with onedoor 30 in the open position, and FIG. 3 which shows cabinet 5 with twodoors 30 in the closed position. Cabinet 5 may further comprise a gasket(not shown) at the interface of the door(s) and frame of cabinet 5 forsealing cabinet 5 when the door(s) is (are) closed.

Interior chamber 10 of cabinet 5 is preferably also equipped withshelves 45 for supporting surgical trays within chamber 10.

Furthermore, cabinet 5 comprises one or more vents 35 formed in thecabinet top 40 and/or cabinet bottom 25. Vent 35 is covered by a filter50, and a filter cover 55 holds filter 50 in place against vent 35.

In order to move cabinet 5 into an autoclave or into an operating roomor storage room, cabinet 5 comprises wheels 20 mounted directly tocabinet bottom 25. In use, medical instruments and/or instrument traysare positioned on shelves 45, and the shelves are loaded into interiorchamber 10 of cabinet 5. Alternatively, shelves 45 may be loaded intocabinet 5 and then the medical instruments and/or instrument trayspositioned on shelves 45. Then the entire cabinet 5 is wheeled into anautoclave which is subsequently activated. The hot air and steamgenerated by the autoclave is able to penetrate into interior chamber 10of cabinet 5 by way of vents 35, thereby sterilizing cabinet 5 and itscontents. At the end of the autoclaving cycle, cabinet 5 is removed fromthe autoclave, allowed to cool, and then moved to a storage space ordirectly to an operating room or other space for use in connection witha medical procedure. Sterilized cabinet 5 is kept closed until such timethat its contents are required for a medical procedure. So long ascabinet 5 is kept closed, the contents will remain sterile, inasmuch asfilters 50 prevent the passage of contaminants through vents 35 into theinterior of the cabinet.

While the introduction of mobile sterilization cabinets has allowed forsignificant savings and efficiencies in hospital sterilizationprocedures, several shortcomings remain. For example, existing prior artcabinets can be difficult to maneuver into and out of an autoclave andcan be difficult to maneuver around a hospital (e.g., to a storage areaor an operating room).

Further, existing cabinets 5 can be difficult to store in increasinglycrowded hospitals where space is frequently at a premium. In addition,opening existing cabinets at the desired time can significantly expandthe footprint of the existing cabinets, inasmuch as space must beallocated to accommodate the swing radius of the door(s).

In addition, existing cabinets can sometimes retain water in the bottomof the cabinet at the end of the autoclave cycle. This is undesirablefor several reasons, one of which is that the water can serve as aconduit through which contaminants can be “pulled” (e.g., by a wickingaction, through a filter 50 in cabinet bottom 25 and into interiorchamber 10).

It can also be difficult for medical personnel to visually assess thecurrent status of existing cabinets or their contents. For example, itis difficult for personnel to know whether an existing cabinet that hasbeen autoclaved is still too hot to handle or whether it has cooled tothe point where it may be safely handled. Similarly, it can be difficultfor personnel to visually ascertain or verify the status and/orinventory of the contents inside of an existing cabinet without havingto open the cabinet and thereby violate the sterile field.

Additional shortcomings of existing cabinets include cumbersome interiorshelving, an inability to sufficiently isolate smaller areas within thecabinet, difficulty in accessing and changing filters, etc.

Still other deficiencies of existing cabinets are known to those skilledin the art.

Thus there is a need for a new and improved mobile sterilizationapparatus and method for sterilizing medical instruments and devices,storing the sterilized medical instruments and devices in a sterilecondition until use, and then delivering the sterilized medicalinstruments and devices to a location where a medical procedure will beperformed, that does not suffer from one or more of the disadvantagesassociated with the prior art.

SUMMARY

The present invention provides new and improved methods for confirmingthe integrity of one or more seals on a mobile sterilization apparatusand devices for confirming the integrity. These methods and devicesallow for sterilizing medical instruments and devices, for storing thesterilized medical instruments and devices in a sterile condition untiluse, and then delivering the sterilized medical instruments and devicesto a location where a medical procedure will be performed.

In one example, the present disclosure includes a method for confirmingintegrity of a sterilization container. For example, such a methodincludes closing a sterilization container having at least one ventedarea that allows fluids to pass into and out of the sterilizationcontainer where the at least one vented area is located in a panel of awall or a door of the sterilization container; positioning a firstfilter to fully cover the at least one vented area and such that thefirst filter extends beyond a perimeter of the at least one vented area;engaging a portion of the first filter to the panel of the sterilizationunit at an area beyond the perimeter of the at least one vented area;positioning a second filter over the first filter such that the secondfilter covers the at least one vented area; affixing an edge of a filtercover against the sterilization unit to engage the second filterdirectly against the first filter and the first filter against the panelsuch that the edge forms a seal simultaneously with both the firstfilter and the second filter against the sterilization unit (inalternate variations the seal is formed sequentially rather thansimultaneously); initiating a sterilization cycle on the sterilizationunit to sterilize an internal region of the sterilization unit;loosening the filter cover from the sterilization unit to disengage theseal of the edge from both the first filter and the second filteragainst the sterilization cabinet; detaching the second filter from boththe first filter and the sterilization unit, where the first filterremains engaged to the panel; and examining the second filter to assessan integrity of the first filter without removing the first filter fromthe sterilization unit. Clearly, the user can examine the integrity ofboth filters as well. Variations of the container include the ventedarea in a top/roof, bottom, or side of the container. In an additionalvariation, a user of the container can simply loosen the filter coverfrom the second filter only to check the second filter first, leavingthe first filter and first filter cover intact.

Another variation of the method includes securing the first filterbetween the panel of the sterilization unit and a frame plate, where theframe plate is secured to the panel. Variations include a frame platethat is detachably secured to the panel, a frame plate is moveablesecured to the panel, and a hinge or other structure securing the frameplate to the panel.

The frame plate described herein can include any geometric outer profileshape as long as the frame plate allows passage of a fluid therethrough.In one example, the frame plate comprises a ring shape. In addition, theframe plate can comprise any material used in sterilization devices,including but not limited to a material selected from the groupconsisting of a metal, a polymer, a composite material. The frame platecan be disposable or reusable.

Variations of the methods and devices described herein include the edgeof the filter cover positioned within a perimeter of the frame plate.

As noted herein, closing the sterilization container can include loadingat least one surgical tray containing a surgical instrument into theinterior sterilization container prior to closing the sterilizationcontainer.

Again, the methods and devices described herein allow relocation of thesterilization cabinet to a sterile location after examining the secondfilter to assess the integrity of the first filter without removing thefirst filter from the sterilization unit.

Another variation of a method for sterilizing a medical item comprisessecuring a sterilization container with the medical item therein whereinthe sterilization container includes at least one vented area in a panelof a wall or a door allowing fluids to pass into and out of thesterilization container; positioning a first filter to cover the atleast one vented area and extend beyond a perimeter of the at least onevented area; engaging a portion of the first filter to the panel of thesterilization container at an area beyond the perimeter of the at leastone vented area; positioning a second filter over the first filter suchthat the second filter covers the at least one vented area; affixing anedge of a filter cover against the sterilization container to engage thesecond filter directly against the first filter and the first filteragainst the panel such that the edge forms a seal with the first filterand the second filter against the sterilization container; initiating asterilization cycle on the sterilization container to sterilize themedical item; loosening the filter cover from the sterilizationcontainer to break the seal of the edge, the first filter, and thesecond filter against the sterilization container; detaching the secondfilter from both the first filter and the sterilization container, wherethe first filter remains engaged to the panel; and examining the secondfilter to assess an integrity of the second filter once detached.

Another variation of a method for preparing a medical item forsterilization includes securing a sterilization container with themedical item therein wherein the sterilization cabinet includes at leastone vented area in a panel of a wall or a door allowing fluids to passinto and out of the sterilization cabinet; positioning a first filter tocover the at least one vented area and extend beyond a perimeter of theat least one vented area; engaging a retainer member against the firstfilter to maintain the first filter to the panel of the sterilizationcabinet at an area beyond the perimeter of the at least one vented area;positioning a second filter over the first filter and the retainermember such that the second filter covers the at least one vented area;and affixing an edge of a filter cover against the sterilization cabinetindependently of the retainer member to engage the second filterdirectly against the first filter and the first filter against the panelsuch that the edge forms a seal with the first filter and the secondfilter against the sterilization cabinet.

The present disclosure also includes a sterilization cabinet forsterilizing a medical item. For example such a sterilization cabinet caninclude a sterilization chamber surrounded by a plurality of panels,where at a first panel of the plurality of panels is removable from theplurality of panels to permit placement of the medical item into thesterilization chamber, and where the first panel is securable to atleast one of the plurality of panels to enclose the sterilizationchamber; where at least one of the plurality of panels comprises avented panel having a vented area, where the vented area allows fluidsto pass into and out of the sterilization chamber; a filter retainingstructure that is configured to removably engage a first filter to thevented panel beyond a perimeter of the vented area; a filter coverhaving an edge, where the filter cover is securable to the sterilizationcabinet to engage the first filter and at least a second filter againstthe directly against the vented panel such that the edge forms a sealwith the first filter and the second filter against the sterilizationcabinet; and wherein after a sterilization cycle the edge of the filtercover is disengageable from the vented panel to break seal of the of thefirst filter and the second filter, allowing for removal of the secondfilter from both the first filter and the sterilization cabinet andwhere the filter retaining structure maintains engagement of the firstfilter remains to the vented panel.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other objects and features of the present invention will bemore fully disclosed or rendered obvious by the following detaileddescription of the preferred embodiments of the invention, which is tobe considered together with the accompanying drawings wherein likenumbers refer to like parts, and further wherein:

FIGS. 1-3 are schematic views showing a prior art mobile sterilizationcabinet;

FIGS. 4-6, 7A-7D and 8A-8D are schematic views showing a novel mobilesterilization system comprising a novel sterilization cabinet and anovel transfer cart;

FIG. 9 is a schematic view showing a further embodiment of the novelsterilization cart of the present invention;

FIG. 10 is a schematic view showing another embodiment of the novelsterilization cart of the present invention;

FIG. 11 is a schematic view showing an electronic control system of themobile sterilization system of the present invention;

FIG. 12 is a schematic view showing a universal transfer cart formed inaccordance with the present invention;

FIGS. 13-21, 22A, 22B, 23, 24, 25A and 25B are schematic views showingfurther details of the mobile sterilization system of the presentinvention;

FIG. 26 is a schematic view showing a novel sterilization cabinet formedwith multiple internal sterilization chambers;

FIG. 27 is a schematic view showing a status indicator feature of thesterilization cabinet of the present invention;

FIG. 28 is a schematic view showing a mobile sterilization systemcomprising external shelving;

FIGS. 29A-D and 30A-D are exploded schematic views of a novelsterilization cabinet formed in accordance with the present invention;

FIG. 30E is a schematic view of a novel docking station formed inaccordance with the present invention;

FIGS. 31-41 are photographs of an improved drain and filter assembly forthe sterilization cabinet of the present invention; and

FIGS. 42-45 are schematic views of the improved drain and filterassembly of FIGS. 31-41.

FIG. 46A-46F illustrates an improved method for maintaining and ensuringsterility of a chamber of a sterilization container/cabinet.

DETAILED DESCRIPTION

The present invention provides a new and improved mobile sterilizationapparatus and method for sterilizing medical instruments and devices,for storing the sterilized medical instruments and devices in a sterilecondition until use, and then delivering the sterilized medicalinstruments and devices to a location where a medical procedure will beperformed.

Looking now at FIG. 4, there is shown a novel mobile sterilizationsystem 100 comprising a novel sterilization cabinet 105 and a noveltransfer cart 200.

Sterilization cabinet 105 typically comprises a rectangular-shapedinterior chamber 110 (FIG. 13) surrounded by a cabinet bottom 125,cabinet side walls 126, a cabinet back wall 127 and a cabinet top 140.Cabinet 105 may further comprise one or more doors 130 to selectivelyopen up or close off interior chamber 110 novel mobile sterilizationsystem 100 of cabinet 105. Cabinet 105 may further comprise a gasket(not shown) at the interface of the door(s) and frame of cabinet 105 forsealing cabinet 105 when the door(s) are closed.

Interior chamber 110 of cabinet 105 is preferably also equipped withshelves 145 (FIG. 23) for supporting surgical trays or instruments, etc.within chamber 110.

Furthermore, cabinet 105 comprises one or more vents 135 formed in atleast one of the cabinet side walls 126, cabinet back wall 127, thecabinet top 140 and cabinet bottom 125. Vent 135 is covered by a filter150, and a filter cover 155 (FIG. 23) holds filter 150 in place overvent 135. Further details of sterilization cabinet 105 (e.g.,improvements to doors 130, filters 150, shelves 145, etc.) will bediscussed in further detail below.

In order to move sterilization cabinet 105 along a surface (e.g., alonga floor, along transfer cart 200, etc.), sterilization cabinet 105comprises a plurality of casters or wheels 160 (generally shown in thefigures in schematic form). In one preferred form of the invention,casters or wheels 160 are mounted to cabinet bottom 125, e.g., via awheel or caster bracket (see below) of the sort well known in the art.Note that casters or wheels 160 are not visible in a number of thefigures due to the angle of view of those figures, however, wheels orcasters 160 can be clearly seen in FIGS. 7C, 13, 22A, 22B, 23, 24, 25A,27, 29D, 30D, 36, 37, 39, 41, 43 and 44.

While sterilization cabinet 105 can be moved along a floor via itscasters or wheels 160, in many situations it can be desirable to movesterilization cabinet 105 on transfer cart 200, e.g., into an autoclaveor into an operating room or storage room.

More particularly, transfer cart 200 provides a platform upon whichsterilization cabinet 105 may be positioned for transport betweenlocations. By way of example but not limitation, transfer cart 200 maybe used to move sterilization cabinet 105 from one part of a facility toanother (e.g., a sterile processing department or an autoclave to anoperating room). In addition, and again by way of example but notlimitation, transfer cart 200 may be used to transfer sterilizationcabinet 105 into and out of storage, and/or to move sterilizationcabinet 105 into and out of an autoclave, and/or to move sterilizationcabinet 105 between facilities or hospital rooms.

Transfer cart 200 generally comprises an upper platform 205 (FIG. 4) forreceiving sterilization cabinet 105, a lower platform 210 to which amechanism (e.g., wheels) for moving the transfer cart between locationsis mounted. Vertical risers 215 extend between upper platform 205 andlower platform 210. Transfer cart 200 preferably also comprises a handle220 for maneuvering transfer cart 200 between locations.

Looking now at FIGS. 4 and 5, transfer cart 200 comprises swivelingcasters 225 for moving transfer cart 200 between locations. Casters 225may be adjusted between a swiveling condition and a non-swivelingcondition by way of easily-accessed, foot-operated pedal adjustment(s)on casters 225, or by way of adjustments performed from a handle 220. Inother words, a user is able to adjust casters 225 from a firstconfiguration wherein the casters are swivelable and a secondconfiguration wherein the casters 225 are locked against swiveling. Thisfeature allows a user to exercise additional control over transfer cart200 when it is being moved between locations. Casters 225 can also beanti-static as an added safety feature.

Preferably, transfer cart 200 may be provided with a compliantshock-absorbing suspension system that enables a smoother “ride” overvarying terrain and inclines as well as during shipping with, andwithout, instrument trays (loaded with medical instrumentation or othercontents) being positioned in sterilization cabinet 105.

By way of example but not limitation, mobile sterilization system 100may be transported fully loaded by remotely-located sterile processingcompanies to and from medical or other facilities that are sometimeshundreds of miles away from a remotely-located sterile processingfacility. The shock-absorbing suspension system allows for improvedsafety and security of the loaded medical instrument trays to limitpossible damage and/or displacement caused during transportation.

As shown in FIG. 5, a shock-absorbing suspension system may compriseshock-absorbing suspension springs 230 positioned on casters 225 and/orresilient springs 235 mounted between upper platform 205 and lowerplatform 210 in place of vertical risers 215.

Alternatively, vertical risers 215 may be formed in a telescopicconfiguration and resilient springs 235 may be disposed around and/orinside telescopic vertical risers 215. Resilient springs 235 are set soas to bias upper platform 205 and lower platform 210 away from oneanother, so as to provide shock absorption functionality for upperplatform 205 (and sterilization cabinet 105) when casters 225 encountera bump or some other surface abnormality that would cause a shock totransfer cart 200. Additional shock-absorbing springs 230 or resilientsprings 235 may be mounted to any other load-bearing parts of transfercart 200 so as to provide shock absorption during transportation ofmobile sterilization system 100.

Transfer cart 200 may also comprise a “dead man's” safety grip and/orauto-braking system. More particularly, and still looking at FIG. 5,there is shown a dead man's safety grip 240. Dead man's safety grip 240is connected (either electronically, mechanically or otherwise) to oneor more wheel brakes capable of preventing casters (or other wheels)from moving (not shown). In one form of the invention, the wheel brakesare configured so that their default position is with the brakes appliedto casters 225 of transfer cart 200, thereby prohibiting movement oftransfer cart 200. When dead man's safety grip 240 is actuated by auser, the wheel brakes are moved to a second configuration, whereby toallow the wheels to roll freely. Accordingly, the wheels (and, byextension, the transfer cart) are prevented from rolling unless deadman's safety grip 240 is actuated. This feature provides foolproofbraking during loading and unloading of sterilization cabinet 105 ontotransfer cart 200, and during loading and unloading of the contents ofsterilization cabinet 105.

Transfer cart 200 may also comprise a power assist mechanism 245 (FIG.4) which can be built into, or otherwise attached to, transfer cart 200.As shown in FIG. 5, power assist mechanism 245 may comprise a motorconfigured to drive casters 225 when a motor/servo power assist handleor other control (not shown) is actuated by a user (e.g., by turning thehandle, in the manner of a motorcycle throttle grip). Power assistmechanism 245 may assist in the transportation of heavier loads forlonger distances, on inclines and/or over uneven surfaces. Power assistmechanism 245 may drive the wheels either forward or in reverse.

In one embodiment, and looking now at FIG. 6, transfer cart 200 may beprovided with a mechanism for linking the transfer cart to one or moreother transfer carts 200 so that the transfer cart may be used to tow(or push) another transfer cart during transport between locations. Toeffectuate such linking capability, transfer cart 200 may be providedwith a male component 250 at one end of lower platform 210 of transfercart 200 and a female component 255 disposed at the opposite end oflower platform 210 of transfer cart 200, whereby to allow the male orfemale component of a given cart to be linked with the complementarymale or female component on another cart. One or both of male component250 and female component 255 can be retracted or folded under transfercart 200 when the transfer cart or tugging/linking feature is not inuse.

In one embodiment, transfer cart 200 may also be configured with bumpersand/or rollers 260 (FIG. 7A) to protect transfer cart 200 and/or otherobjects, and to otherwise facilitate movement of transfer cart 200 fromone location to another (e.g., during transportation through a hospitalhallway).

Looking now at FIGS. 7A-7D, transfer cart 200 is preferably releasablysecured to cabinet 105 by a combination of complimentarily configuredtracks or rails and a locking latch or similar device.

Preferably, transfer cart 200 is provided with an improved safetyfeature of interlocking tracks or rails to catch interlocking casterbrackets (which mount to casters or wheels 160 to cabinet 105). Moreparticularly, lips 265 extend inboard from a pair of transfer carttracks or rails 270, which themselves extend upward from a side or topsurface of upper platform 205 of transfer cart 200 (i.e., with one trackor rail 270 extending along each side of transfer cart 200). Lips 265are configured to slidably engage elongated projection 165 of cabinetcaster or wheel bracket 170 so as to prevent sterilization cabinet 105from moving either laterally (i.e., side-to-side), or up-and-down, withrespect to transfer cart 200 while cabinet 105 is positioned on transfercart 200.

Transfer cart 200 and sterilization cabinet 105 are preferably formed soas to provide autolocking features to keep cabinet 105 secured totransfer cart 200. More particularly, and looking now at FIGS. 7A and7B, transfer cart 200 may be configured with a center locking latch 275that is mounted to upper platform 205 of transfer cart 200. Centerlocking latch 275 may be configured to receive a bar 175 which extendsacross the bottom of sterilization cabinet 105 such that, after bar 175is received by latch 275, sterilization cabinet 105 is prohibited frommoving forward or backward with respect to transfer cart 200.

Transfer cart 200 is preferably configured so as to be “universal” byproviding railings and attachments that are adjustable so as to be ableto accommodate the dimensions of different sterilization cabinets orother cargo, and/or the dimensions of different destinations ofsterilization cabinet 105 (e.g., different autoclaves or storage racks).

More particularly, and looking now at FIGS. 8A-8D, transfer cart 200 maybe configured with universal railings 280 which are of adjustable widthalong directional arrow 1 or 3 shown in FIG. 8A, and a detachableadapter 285 which is also configured to be of adjustable width.Adjustable rails 280 and adapter 285 may be fit together, such as in themale/female configuration shown in FIG. 8B, so as to allow for a smoothsurface for the transfer of sterilization cabinet 105 from transfer cart200 to a destination (e.g., a storage rack, autoclave, etc.). The widthof universal rails 210 and adapter 285 is determined at least in part byreference to the width of the corresponding features at the destination(e.g., it may be determined by the width of a storage rack or therelevant components of an autoclave).

Adapter 285 may be configured to extend straight out above upperplatform 205 (such as is shown in FIG. 8A), or to fold down (such as isshown in FIGS. 8C and 8D) so as to not protrude at the end of transfercart 200. Alternatively, adapter 285 may be configured so as to beentirely removable from the transfer cart. Where detachable adapter 285is configured to be removable from transfer cart 200, adapter 285 may befurther configured to be stowed in an unobtrusive location on transfercart 200, or it may be configured to be stored near a destinationlocation for ready use.

The universal fit feature described above improves production capacity,lowers cost, and enhances the ease and safety of moving mobilesterilization system 100 (e.g., through hospital hallways). When adapter285 is removed and/or folded away (such as shown in FIGS. 8C and 8D), ablunt-nosed, shorter and less dangerous cart front is presented at thefront end of mobile sterilization system 100. As discussed previously,adapter 215 may either stay with each transfer cart 200 as a folding orstowable component or it may be left at a desired destination (e.g., ina sterile processing department to be stored adjacent to the autoclaveor next to a storage rack or rack system).

In another embodiment of the present invention, an alternative transfercart is provided which is capable of being vertically adjusted so as toraise and lower the upper platform of a transfer cart (and, in turn, asterilization cabinet 105 secured to the upper platform) in order tomeet the needs of a user. By way of example, the upper platform of thetransfer cart can be lowered for easier visibility during transportationbetween locations, and then raised to a desired height when thesterilization cabinet is opened at a desired location.

The vertically-adjustable transfer cart may be raised and loweredmechanically (e.g., such with a scissor lift, as will be discussed infurther detail below) electronically, hydraulically, pneumatically, by abattery-operated power device, or by some other appropriate means.

To this end, and looking now at FIG. 9, a vertically-adjustable transfercart 300 is provided.

Vertically-adjustable transfer cart 300 is generally similar to transfercart 200 discussed above, except that vertical risers 215 and lowerplatform 210 are replaced by a scissor lift 315 having an upper end 320and a lower end 325.

Sterilization cabinet 105 is configured to be secured to upper platform305 of transfer cart 300 in the same manner discussed above. Scissorlift 315 is connected to upper platform 305 at its upper end 320 and towheels 330 at its lower end 325 for moving the transfer cart betweenlocations.

In accordance with this aspect of the invention, scissor lift 315 may beactuated so as to enable upper platform 305 to be lowered until it issubstantially flush with the floor.

In another embodiment of the present invention, and looking now at FIG.10, a vertically-adjustable transfer cart 400 is provided. Transfer cart400 is generally similar to transfer cart 200 discussed above, exceptthat vertical risers 215 are replaced by a scissor lift 415 having anupper end 420 and a lower end 425.

More particularly, transfer cart 400 comprises an upper platform 405which is configured to be secured to sterilization cabinet 105 asdiscussed above, a lower platform 410 and a scissor lift 415 extendingbetween upper platform 405 and lower platform 410.

Actuation of scissor lift 415 in this embodiment will move upperplatform 405 up and down, as described above, however, upper platform405 is not lowered all the way to ground level (i.e., it is lowered tothe level of lower platform 410). This embodiment can provide additionalstability for transfer cart 400.

Scissor lifts 315 and 415 of transfer carts 300 and 400, respectively,may be actuated (i.e., raised and lowered) by a lift mechanism that canbe a mechanical hand-crank or hydraulic or pneumatic hand-pump, or whichmay be power-assisted (mechanical, hydraulic, pneumatic, etc.) viaelectric or battery operation.

In addition, transfer carts 300 and 400 may comprise an electroniccontrol system (such as that shown in FIG. 11 and discussed in moredetail below) which may allow a user to pre-program specific heightsinto the electronic control system, which will direct the transfer cartto assume a desired height (e.g., for loading the sterilization cabinetinto a particular autoclave, or a preferred height for operating room orsterile processing department staff who will unload, load or transportthe sterilization cabinet). This feature allows for height adjustments,thereby providing ergonomic benefits without compromising the sterilefield on account of the nurse or scrub technician's physical stature.

An additional benefit of the height adjustment feature described aboveis that the sterilization cabinet can be lowered to allow for betterline of sight over the top of the cabinet during transportation and toprovide a lower center of gravity so as to reduce the possibility oftipping. The pre-programmed heights may be set by the user as discussedabove.

Looking now at FIG. 11, the transfer cart of the present invention (e.g., transfer carts 200, 300 and 400) may also be provided with anelectronic control system 290 for tracking and/or identifying thetransfer cart and the contents of sterilization cabinet 105.

More particularly, electronic control system 290 of the transfer cart ofthe present invention preferably has the ability to be electronicallytraced with a LOJACK®-like device, or a similar tracing-type system. Inother words, the location of the transfer cart (e.g., building, floor,room) may be remotely monitored by use of a global positioning system(GPS), radio-frequency identification (RFID), or other location-trackingdevice.

In addition, electronic control system 290 may use RFID, or otheridentification technology, to identify a particular sterilizationcabinet 105, the contents of that sterilization cabinet 105 (e.g., traysor instruments), its location, current temperature, and/or sterilizationstatus (e.g., pre- or post-sterilization, sterile or non-sterile, etc.).Electronic control system 290 may also provide additional informationsuch as date, operator, cycles, cycle type, and contents insidesterilization cabinet 105, among other things.

The information provided by electronic control system 290 may bedisplayed on a screen to a user, or audibly delivered through a speakerto a user.

Looking now at FIG. 12, a universal transfer cart 500 is provided.Universal transfer cart 500 may act as a transfer cart for otherapparatus (e.g., an interchangeable case cart component 505 for holdinginstrument trays, but not sterilizing instrument trays) in addition toacting as a transfer cart for sterilization cabinet 105. Sterilizationcabinets and case cart components can be vertically stacked on storageracking systems, e.g., up to 4 cabinets high. See, for example, FIG. 20,which shows (schematically) two sterilization cabinets 105 verticallystacked on top of one another.

Looking now at FIGS. 13-27, additional features of sterilization cabinet105 will now be discussed in further detail.

In a preferred form of the present invention, door 130 can be providedin a variety of configurations in order to minimize the footprint neededwhen access to the interior of sterilization cabinet chamber 105 isrequired.

In one embodiment of the present invention, and looking now at FIG. 13,door 130 can be hinged to one side of sterilization cabinet 105 andopened 180 degrees.

In another embodiment of the present invention, and looking now at FIG.14, door 130 can be mounted to cabinet side wall 126 with hinges 180 soas to allow door 130 to open 270 degrees. If desired, door 130 and sidewall 126 may be equipped with apparatus (e.g., a “hook and mesh”fastener, such as a Velcro™ fastener) so as to allow door 130 to bereleasably secured to side wall 126 of cabinet 105 in order to keep theopen door proximate to (and roughly parallel to) side wall 126 ofcabinet 105, thereby reducing the overall footprint of cabinet 105 whendoor 130 is open.

In another embodiment of the present invention, and looking now at FIG.15, door 130 can comprise a pair of French doors 130, with a gasket orother sealing closure in the middle of, and around, each door 130 (notshown), and with both French doors 130 optionally being configured to beopened and releasably attached to the side of the cabinet in the mannerdescribed above.

In still another embodiment of the invention, and looking now at FIGS.16 and 17, door 130 can be opened and slid down (as in FIG. 16) or up(as in FIG. 17) along an internal or external track (not shown)positioned along the left and/or right side walls 126 of sterilizationcabinet 105. Alternatively, door 130 may be swung over the top ofsterilization cabinet 105 (not shown).

In yet another embodiment of the present invention, and looking now atFIG. 18, door 130 may comprise one or more bi-fold door(s) 130 which maybe opened (and folded away) so as to expose interior chamber 110. In onepreferred form of the invention, bi-fold door(s) 130 are constructed sothat they may be folded back 270 degrees (e.g., in the manner describedabove) so that door(s) 130 may be positioned approximately parallel toside wall 126 of sterilization cabinet 105. Additionally, bi-folddoor(s) 130 and side walls 126 are preferably constructed so as to allowdoor(s) 130 to be releasably secured to side walls 126 (e.g., with a“hook and mesh” fastener, e.g., a Velcro™ fastener) when door(s) 130 arefolded back against side walls 126.

In another form of the present invention, the sterilization cabinet canhave a dome closing top (not shown) rather than a door, i.e., the top ofthe sterilizable cabinet can move upward to expose the contents of thesterilization cabinet. The shape of the dome top is generally configuredto allow for an airtight fit around the sterilization cabinet.

Accordingly, the dome top may be any shape that allows it to be properlyfit over the top of the frame of sterilization cabinet 110. In thisembodiment, the dome top can be lifted (e.g., manually, mechanically,with electronic assist, etc.) to expose the contents of sterilizationcabinet 105. If desired, the dome top may be formed of a transparentmaterial so as to allow full visibility of the contents withinsterilization cabinet 105.

In still another form of the present invention, and looking now at FIG.19, sterilization cabinet 110 may comprise a frame wherein back wall127, side walls 126 and door(s) 130 can be loosened from frame 185 andslid down along internal or external tracks to the outside of thetransfer cart 200. In this embodiment of the invention, handle 220 oftransfer cart 200 may be removable so as to facilitate the smoothsliding of the side walls and/or door along the tracks.

In another preferred form of the present invention, means may beprovided to enable a user to assess the contents of the sterilizationcabinet without having to open the door of the sterilization cabinet.

More particularly, the entire sterilization cabinet 105 may be formedout of a transparent material (e.g., glass, a transparent polymer, etc.)so as to provide visibility to the contents within the sterilizationcabinet. See, for example, FIG. 20, which shows a transparentsterilization container 105 positioned on top of transfer cart 200, anda second non-transparent sterilization container 105 positioned on topof transparent sterilization container 105.

In another embodiment, and looking now at FIG. 21, sterilization cabinet105 may be provided with one or more windows 190 (or “oven doors”)located on one or more of the side walls 126, back wall 127 or door(s)130 of sterilization cabinet 105. This allows for visibility into thecabinet to ascertain the contents of the cabinet and whether all of thedesired equipment and instruments are enclosed.

If desired, the entire cabinet or window(s) 190 may be formed of a hightemperature polycarbonate material and/or a “switchable” smartglass/film that changes from clear to opaque and/or another suitablematerial (e.g., to indicate a “sterile” or “non-sterile” state).

In another form of the present invention, an improved filter and filterport is provided in order to improve access to the filter for replacing,or otherwise accessing, the filter. Looking now at FIGS. 22A and 22B,sterilization cabinet 105 may be provided with filter ports 152 that areaccessible from the outside of the cabinet, thereby allowing for easieraccess to check and change filters 150 (e.g., easier than with filtercover 155). By way of example but not limitation, externally accessiblefilter port 152 may comprise a drawer-type access shelf for slidablyreceiving filters 150 and positioning the filter over vent 135. Afterbeing slidably placed in the desired position over vent 135 in filterport 152, filters 150 may be held in place by a locking bar 154 whichcontrols a cam mechanism 156 (which releasably locks filters 150 inplace).

Filter 150 may comprise cardboard, filter cassettes, reusable carbonfilters or other filter materials and constructions known in the art.Filter 150 may also be a bi-layer filter created by sewing, gluing,encasing, crimping or pressing two layers of filter material togetherand forming to a desired size. Filter 150 may also be configured tochange color to convey information concerning their status (e.g., afirst color may indicate that a filter is suitable for use, while asecond color may indicate that a filter should not be used and should bereplaced, etc.). Thus, in one preferred form of the invention, thefilter is manufactured using a process that incorporates chemical (s)into or onto the filter (in whatever pattern desired, including onerequested by the customer) that will change color after thesterilization cabinet has been sterilized (as long as the sterilizationprocess met certain predetermined parameters). In other words, thefilters themselves become a Class 5 status indicator in addition to allof the other indicators which may be used during the sterilizationprocess. This type of filter is a great improvement over the filterscurrently available on the market, as it provides a fail-safe mechanismto ensure that single use disposable filters are used only once. It alsoenables the operating room staff to visually confirm that the processhas been accomplished by a quick glance at the large filter material.

Filters 150 may also be used for purposes other than in conjunction withan existing sterilization cabinet and/or mobile sterilization system100.

In some applications of the present invention, it may be appropriate tonot use any filters with the cabinets.

Looking again at FIG. 13, sterilization cabinet 105 may have a drain 195positioned in the cabinet floor 125 to allow for the removal of waterthat may have accumulated within the cabinet during the sterilizationprocess. In this construction, drain 195 is placed at the lowest pointin the bottom of sterilization cabinet 110. Preferably, bottom panel 125is designed with a pitch to the lowest point in the panel, whether inthe middle of the panel or along one side of the panel or in a corner ofthe panel. One or more drains may be used in each cabinet.

If desired, drain 195 may be thermostatically-controlled. In this formof the invention, drain 195 may be formed with a so-called “bimetallic”construction, e.g., a shape memory alloy such as Nitinol which canchange configuration in response to temperature changes. By way ofexample but not limitation, drain 195 may be configured to open when thetemperature within the sterilization cabinet is higher in order torelease the excess water created during the sterilization process, andto close when the temperature within the sterilization cabinet is lowerso as to seal the sterilization cabinet from potential containments.

In another embodiment, drain 195 may be configured to open and closedepending on the pressure level within the sterilization cabinet. By wayof example but not limitation, drain 195 may be configured to open whenthe pressure within the sterilization cabinet is within a certain levelin order to release the excess water created during the sterilizationprocess, and to close when the pressure within the sterilization cabinetis within a certain level so as to seal the sterilization cabinet frompotential containments.

In still another embodiment, drain 195 may be configured to open andclose depending on the amount of time that has lapsed since thesterilization process. By way of example but not limitation, drain 195may be configured to open during the time it takes to sterilize thecontents of the sterilization cabinet in order to release the excesswater created during the sterilization process, and to close after thecontents of the sterilization cabinet have been sterilized so as to sealthe sterilization cabinet from potential containments.

In a further embodiment of the present invention, sterilization cabinet110 comprises improved shelf management options so as to provide lesscumbersome interior shelving than prior art sterilization cabinets.

More particularly, and looking now at FIG. 23, sterilization cabinet 105may be configured with “wrinkle walls” or stamped walls 146 for ease ofremoving and replacing shelves 145 at multiple heights without the needfor adjusting clips within the cabinet. In this aspect of the invention,shelves 145 are adjustable into varying height positions, whichadjustments may preferably be accomplished with one hand (e.g., throughthe use of “squeeze and release” shelving or other similaralternatives).

Alternatively, and looking now at FIG. 24, shelving supports 147 may bebolted to cabinet 110 so as to support shelves 145.

In still another aspect of the invention, and looking now at FIGS. 25Aand 25B, shelves 145 may be attached to shelving supports 147 byspring-loaded pegs 148.

In another embodiment, drawer-style shelves may also be used (notshown). In addition, the shelves may be constructed of various materialswhich may aid in the sterilization process and/or provide otheradvantages (e.g., the shelves may be formed of aluminum for better heattransfer, or may be formed of materials that are less expensive, etc.)

In another embodiment, the present invention provides a sterilizationcabinet which has the ability to isolate smaller areas inside of thesterilization cabinet.

More particularly, and looking now at FIG. 26, sterilization cabinet 105is configured so as to provide multiple chambers 110 within cabinet 105.More particularly, in this form of the invention, sterilization cabinet105 comprises separate individual chambers 110, each of which areaccessible by a separate door 130. Preferably, each chamber 110 isprovided with its own vent 135 and filter 150 to allow for steam or heatpenetration during the sterilization process. In addition, eachindividual chamber 110 may have a sterile/unsterile indicator 197 (ofthe same or a similar type as will be described in greater detail below)to indicate the sterile/non-sterile condition of that compartment.

Compartmentalization provides the option of the contents of the severalchambers 110 being used in different procedures. In other words, allchambers 110 and their contents can be sterilized at the same time, andthen the contents of individual chambers 110 can be used withoutcompromising the sterility of the other chambers 110 or their contents.By way of example but not limitation, four trays (placed in one or morechambers 110) can be brought to an operating room for a “4 trayprocedure” (i.e., a medical procedure requiring those four trays ofsterilized medical instruments), and another eight trays placed in aseparate set of chambers within the same sterilization cabinet 105 canbe brought to a second operating room for an “8 tray procedure” (i.e., amedical procedure requiring those eight trays of sterilized medicalinstruments). Compartmentalized sterilization cabinet 105, incombination with transfer cart 200, can thus serve as a delivery systemfor more than one medical procedure, providing several efficienciesincluding, but not limited to, requiring fewer staff to deliver thesterile trays and requiring less equipment to deliver the trays to thedesired location.

In addition to the foregoing, sterilization cabinet 105 may be providedwith additional features for assisting in the determination of thecompletion of the sterile processing or for providing additionalinformation about the status of the cabinet (e.g., whether thesterilization cabinet is too hot to open).

By way of example but not limitation, such additional features mayinclude indicators on the windows or panels of the cabinet that changecolor after sterile processing of the cabinet and then change back afterthe cabinet is opened (and hence rendered non-sterile).

In addition, and looking now at FIG. 27, an external indicator 197positioned on the cabinet itself may indicate when the cabinet is toohot to touch (e.g., by “lighting up” or otherwise making the “hot”indicator more visually prominent than the “cold” indicator) and/ormaking the “hot” indicator less visually apparent when the cabinet hasreached appropriate handling temperature. Similarly, another indicator198 may indicate whether the door of the cabinet has been opened (e.g.,by “lighting up” or otherwise making the “UNSTERILE” indicator morevisually prominent than the “STERILE” indicator). The indicators mayalso provide other information to a user in the manner described above(e.g., whether the door has been “OPENED” or has remained “CLOSED”).

Sterilization Cabinet Sizing and Configurations

Sterilization cabinet 105 can be fabricated in many sizes including, butnot limited to, sterilization cabinets that can be specifically sized toreceive four trays, or eight trays, or nine trays, or twelve trays, etc.

Furthermore, and looking now at FIG. 28, each size cabinet can also bemanufactured with separate external shelving 600 positioned on theexterior of one or more side walls 126 for maximizing space usage (e.g.,in the autoclave chamber for each cycle in the autoclave). Externalshelving 600 can accommodate additional trays of wrapped instruments orrigid containers and is attachable to cabinet 105 for easy unloadingwhen the cycle is completed. External shelves 600 may be individuallymounted to the outside of cabinet 105 (as in the case of externalshelving 600). Alternatively, the external shelves can take the form ofa rack 650 which can be removably attached (e.g., clipped to) a sidewall 126 of sterilization cabinet 105. Each shelving unit may come withits own transfer cart according to the size needed, and all shelves maybe compactible or foldable for easy storage when not in use.

Construction Materials

Sterilization cabinet 105 has many options with respect to the rawmaterials for cabinet production. In one preferred form of theinvention, sterilization cabinet 105 may be manufactured out ofstainless steel. However, it should be appreciated that sterilizationcabinet 105 can also be manufactured out of various materials inaddition to stainless steel, including but not limited to aluminum(which may allow for a lighter version of the product and the potentialfor multiple color options during anodizing), or a polymer.

If desired, door handle 132, deadman's safety grip 240 and any othersurfaces that may be handled in order to move mobile sterilizationsystem 100 may be covered with a disposable sanitary wrap or film inaccordance with sterile procedures.

Alternative Configurations

Sterilization cabinet 105 can also be configured to be used as a “backtable” during a medical procedure. More particularly, once thesterilization cabinet is opened (e.g., via either the doorconfigurations discussed above, and/or the dome top discussed above,etc.), the shelves can be displayed to the user using a “toolbox” or“tackle box” design, swinging shelves, or movable shelf system, therebyallowing easy access to all of the inner trays.

Manufacturing Technique

Looking now at FIG. 29, there is shown an exploded diagram of anembodiment of sterilization cabinet 105 which is “bolted together”around an internal frame. More particularly, sterilization cabinet 105may comprise a frame 112, and side walls 126, rear wall 127, top wall140 and bottom wall 125 may be attached to frame 112 to form interiorchamber 110 of cabinet 105. Each of the walls may be attached to frame112 by bolts 113 or other suitable means. A sealant 114 or O-ring typeseal (not shown) may be placed at the interface of frame 112 and betweeneach of the walls so as to ensure an air-tight seal.

In another embodiment of the present invention, and looking now at FIG.30, each of the walls of sterilization cabinet 105 may be boltedtogether without a frame. In this embodiment, each of the side, back,top and bottom panels are attached to one another with bolts 113, with alayer of sealant 114 being applied to the interface between each of thepanels.

The embodiments of the invention shown in FIGS. 29 and 30 may provideadditional advantages including, but not limited to, reduced shippingcosts, inasmuch as the disassembled sterilization cabinet could beshipped in a smaller shipping container (e.g., with the top, bottom,side and back panels and door(s) lying flat against one another). Thesterilization cabinet can then be assembled on-site by appropriatelytrained personnel, who could then verify proper assembly (including anair tight seal) by biological testing methods well known to those in theart.

Docking Station

Mobile sterilization system 100 may also be configured for use with anoptional docking station. Looking now at FIG. 30E, docking station 700comprises a frame 705 and wheels 715. The frame 705 provides a space 720for receiving one or more sterilization cabinets 105. Docking station700 preferably also comprises shelves 725 (which can receive additionalsterilizable instrument containers). Docking station 700 is itselfsterilizable and may be placed directly in an autoclave.

In one preferred form of the invention, transfer cart 200 and dockingstation 700 are configured to be releasably secured to one another. Inthis form of the invention, a user may bring transfer cart 200 (carryingsterilization cabinet 105) up to docking station 700 and then releasablysecure transfer cart 200 to docking station 700 (or otherwise ensurethat neither transfer cart 200 nor docking station 700 will move duringtransfer of sterilization cabinet 105 from transfer cart 200 to dockingstation 700); cabinet 105 may then be easily moved from transfer cart200 onto docking station 700. Transfer cart 200 may then be detachedfrom docking station 700 and docking station 700 (and its passengercontainers) moved into the autoclave for sterilization.

Some advantages of using docking station 700 in conjunction with mobilesterilization system 100 include but are not limited to: (i) moreefficient use of autoclave space inasmuch as the sterilization cabinet110 may be placed on docking station 700 which is also loaded withadditional containers requiring sterilization; and (ii) freeing uptransfer cart 200 for other uses after sterilization cabinet 105 istransferred from transfer cart 200 to docking station 700.

In this respect it should be noted that, in some forms of the invention,transfer cart 200 is not intended to be sterilizable (e.g., wheretransfer cart 200 carries heat- and moisture-sensitive components suchas electronics, etc.).

Improved Condensation Drain and Filter Ports

In still another form of the present invention, an improved condensationdrain and filter port is provided for significantly enhancing theperformance of sterilization cabinet 105.

More particularly, it has been discovered that the removal of condensatefrom a sterilization cabinet in its liquid form (as opposed to byevaporation) significantly enhances the performance of a sterilizationcabinet. It has been found that steam used during the sterilizationprocess generates a substantial amount of condensate (i.e., liquidwater) during the sterilization process. The condensate flows by gravityto the lowest point of the sterilization cabinet. During the dryingphase of the sterilization process, a vacuum acts on the autoclavechamber. As the pressure of sterilization cabinet is equalizing withthat of the autoclave, the condensation is pulled through a drain (moreparticularly described below) disposed at the lowest point of thesterilization cabinet and out of sterilization cabinet.

More particularly, in another preferred embodiment of the invention, andlooking now at FIGS. 31-45, there is provided an improved drain 800configured to allow condensate to escape sterilization cabinet 105without compromising its sterility. Drain 800 is disposed at the lowestpoint in bottom wall 125 of sterilization cabinet 105. Preferably,sterilization cabinet 105 comprises a pitched floor so that anycondensate is directed by gravity to the lowest point in bottom wall125.

Drain 800 comprises a recess 805 formed below the lowest point in bottomwall 125 of sterilization cabinet 105. Configuring the drain in thismanner prevents any residual moisture from remaining in cabinet 105.Recess 805 may be formed of thick stainless steel or other material soas to retain heat and enhance evaporation of any condensate that hasflowed into recess 805.

Drain 800 preferably comprises a grill plate/screened floor 810 disposedover recess 805. Grill plate/screened floor 810 provides a rigidplatform to support a filter (as is more particularly described below).Grill plate/screened floor 810 is permeable so as to allow condensate topass through it. A filter 815 is disposed on top of grill plate/screenedfloor 810. Filter 815 is configured so as to allow condensate to passthrough it and out of sterilization cabinet 105 while preventingcontaminants from entering sterilization cabinet 105.

A rigid filter door 820 is disposed across recess 805 and on top offilter 815, thereby capturing filter 815 between filter door 820 andgrill plate/screened floor 810. Filter door 820 comprises perforations825 to allow condensate to pass from sterilization cabinet 105 throughfilter door 820. Filter door 820 is also formed with handle 830, whichis held in place by handle brackets 835. Handle 830 allows a user toeasily remove filter door 820 (as described below) so as to provideaccess to filter 815 so that filter 815 may be changed as required.Filter 815 may be changed by removing filter door 820 by twisting handle830 out from under handle brackets 835.

One or more gaskets (not shown) may be placed against one or more sidesof filter 815 (e.g., between filter door 820 and filter 815, and/orbetween filter 815 and grill plate/screened floor 810) so as to form aseal to prevent the passage of microbial contamination.

In addition to the foregoing, it has also been discovered that it may beadvantageous to configure sterilization cabinet 105 with improved filterports 900 (FIG. 36) disposed in the side wall 126 of sterilizationcabinet 105 (in lieu of or in addition to other locations) to allow forimproved steam penetration and airflow and to provide an improvedvent-to-volume ratio. Filter ports 900 may be configured to be circularportals in the panels of sterilization cabinet 105. Filter ports 900 arecovered with circular plates 905 so as to allow for a single point ofattachment 910 (e.g., at the center of the circle) and for an evencompression of filter gaskets (more particularly described below).

Filter ports 900 comprise a filter 915 and a plate 905 havingperforations 920, with filter 915 and plate 905 being mounted to theoutside of sterilization cabinet 105, or mounted to the inside ofsterilization cabinet 105, in alignment with perforations formed in theside panels of sterilization cabinet 105. Perforations 920 allow for thepassage of steam into and out of the sterilization cabinet 105. One ormore filters 915 are positioned intermediate the circular plate 905 andcabinet 105 and prevent the passage of microbial contaminationtherethrough.

Circular plates 905 are provided with gaskets (not shown) so as tocreate an effective seal between plate 905 and filter 915. Plates 905are also provided with a twist handle (not shown) which allows for plate905 to be locked into place and for easy removal when a change of filter915 is required.

In one preferred form of the invention, filter 915 is disposedintermediate plate 905 and the outside of a side panel of sterilizationcabinet 105 so as to allow filter 915 to be accessed from the outside ofsterilization cabinet 105. In another preferred form of the invention,filter 915 is disposed intermediate plate 905 and the inside of a panelof sterilization cabinet 105 so as to allow filter 915 to be accessedfrom the inside of sterilization cabinet 105 for added filterprotection. Filter ports 900 may also be provided with covers (notshown) to prevent damage during transportation.

Filter ports 900 and the components thereof are more consistent with thedesign of other rigid containers in the marketplace, thereby allowingfor a crossover of intuitive training and also for a preferredmanufacturing process.

FIG. 46A-46F illustrates an improved method for maintaining and ensuringsterility of the chamber 110 of a sterilization container/cabinet 105.FIG. 46A illustrates a sterilization cabinet 105 that includes one ormore vented areas or vents 430 in a panel of a wall 126, door 130, backpanel or floor 125 of the cabinet. The illustrated cabinet 105 showsvents 430 in a door 130 and side walls 126 of the cabinet 105 forillustrative purposes only. Variations of the cabinet 105 can includeone or more vents in any location of the cabinet's panels including thetop or bottom of the cabinet 105. In addition, the vents 430, fitters432, 434, retainer 436, and/or seal 440 can include circular shapes asillustrated or other non-circular configurations. The vents can includeany fluid permeable configuration such that a sterilization agent canpass through during a sterilization cycle (including but not limited toa typical autoclave sterilization cycle). The sterilization cabinet 105illustrated in these figures is shown without any shelving or componentswithin the cabinet 105 for purposes of illustrating affixing the doublefilter to the container 105.

FIG. 46B illustrates an exploded view of a filter-seal assembly 450. Asillustrated, the filter-seal assembly 450 includes a first filter 432,an engagement member, which in this example is shown as a retainermember/frame 436, a second filter 434 and a sealing member or filtercover 440. The filters 432, 434 can include any fluidly permeable filtermaterial commonly used for filtration systems, especially those used forsterilization systems.

FIG. 46C shows placement of the first filter 432 against a side wallpanel 126 of the unit 105. The first filter 432 encircles or spansbeyond the vent area 432 so that fluid entering or exiting the adjacentvent 430 must also pass through the filter 432. FIG. 46D illustratesengaging the first filter 432 to the side panel 126. In the illustratedvariation, the filter 432 is engaged to the side panel 126 using aretainer member/frame 436. The retainer member/frame 436 can be securedto the container 105/side panel 126 using standard attachment methods.For example, the panel can include one or more protrusions/threaded rods(not illustrated) that extend outward allowing openings 438 in theretainer member/frame 436 to be positioned over the protrusion such thatthe retainer member/frame 436 removably engages the first filter 432 tothe container 105.

As discussed below, engaging of the first filter 432 to the container105 is desired for checking the integrity of a seal formed by thefilter-seal assembly 450 after the container 105 is processed through asterilization cycle. The first filter 432 must remain engaged againstthe container 105 upon disassembly of the seal member 440 and the secondfilter 434. This construction/feature prevents potential contaminantsfrom entering the container during the unloading process of theinstrument tray. Any conventional means can be used to retain firstfilter 432 against the container 105. For example, the container 105 caninclude a retainer member coupled thereto by a hinge assembly (notshown). Alternatively, or in combination, the container 105 can includeone or more clamping structures that releasably engages the first filter432 against the cabinet wall 126. In certain variations, the retainermember/frame 436 extends beyond (or encircles) a perimeter of the vent430 but remains engaged against the container 105 to sandwich the firstfilter 432 against the container 105. Next, as shown in FIG. 46E, thesecond filter 434 is positioned over the retainer member/frame 436. Inthe illustrated example, the perimeter of the second filter 434 is equalin to a perimeter of the first filter 432, but the second filter canextend beyond the first filter 432 or can be sized smaller than thefirst filter 432 as long as it engages the outward side of the retainermember/frame 436.

FIG. 46F illustrates securing of a filter cover 440 onto the secondfilter 434. The filter cover is designed to cause a seal against thesterilization container 105 such that any fluids entering or exiting thecontainer 105 must pass through the porous/permeable region of thefilter cover 440. In certain variations, securing the filter cover 440causes an edge of the filter cover 440 to engage the second filter 434directly against the first filter 432 and the first filter 434 againstthe panel 126 (or against the container 105) such that the edge of thefilter cover 440 forms a seal simultaneously with both the first filter432 and the second filter 434 against the sterilization unit 105.Alternatively, the seal can form sequentially.

In the variations illustrated in FIGS. 46A to 46F, the engagement of thefirst filter against the sterilization container 105 does not form aseal. Instead, it only causes retention of the filter 432 against theunit 105. The only seal formed about an individual vent is formed by thefilter cover 440 as described above. The purpose of retaining the firstfilter against the unit is to prevent the passage of airbornecontaminants from entering the container during the process of unloadingthe contents of the container. The remaining first filter essentiallyacts as a dust cover. The retention of the first filter against the unitmay be accomplished by a ring or a frame of any kind, with or without agasket forming a complete seal. The primary purpose of this dust coveris to allow thorough inspection of the integrity of the outermost filterand visual confirmation of the presence and integrity of the innermostfilter, enabling the technician to have a high level of confidence thatthe contents are sterile. This prevents the need to set up a secondaryback table until confirmation of the filter integrity can be made. Thetechnician is able to unload the contents of the container directly tothe surgical back table, eliminating a step in the process of the OR setup. There is a reasonable inference that can be made that if theoutermost filter is not compromised, it is extremely unlikely that theinnermost filter is compromised. The innermost filter can then beexamined more closely after the contents of the container have beenaseptically transferred to the back table.

Although the various illustrations show the container 105 in an openconfiguration, the container can be sealed with medical devices thereineither before or after application of the filter seal assemblies. Oncethe container is secured (e.g., the door is closed and seals are formedat each filter) the container 105 is subject to one or more asterilization cycles that sterilizes an internal region of thesterilization unit.

Once the sterilization cycle ends, the container 105 is removed from theautoclave or other sterilization apparatus. The sterilization container105 can then be transferred to a storage area or a surgical area. Priorto opening the sterilization container 105 in a sterile area, a medicaltechnician will check to ensure that the integrity of the filters is notcompromised. The technician will then loosen the filter cover from thesterilization unit to disengage the seal of the edge from the secondfilter 434 (see FIG. 46E). The second filter is then detached from boththe first filter and the sterilization unit (as shown in FIG. 46D),where the first filter remains engaged to the panel (in this casethrough the use of the retainer member/frame 436). The technician canthen examine the second filter to assess it for integrity withoutremoving the first filter from the sterilization unit. This integritycheck of the second filter 434 allows confirmation that the integrity ofthe first filter 432 is not compromised. Because the sterilization cycletypically uses steam, high pressure and elevated temperatures, thefilters 432, 434 have a tendency to stick together. The use of thedouble filter system described herein, which allows the first filter toremain engaged with the container 105, allows confirmation of the sealintegrity without removing the filter 432 from the container 105.

Every minute of setup time in the OR is extremely costly to thefacility. Steps removed from the OR setup process are valuable not onlyfinancially but also add to patient safety. Delays in room setup causedby compromised sterility of instruments are far too common. This methodof thoroughly examining the outermost filter(s) first while leaving adust cover for added protection against contaminants, then removing thecontents of the container directly to the surgical back table, followedby examination of the innermost filter(s) for final confirmation thatthe contents remained sterile, allows for greater assurance of sterilityof the instruments and a higher probability of performing best practicestandards.

MODIFICATIONS

It should also be understood that many additional changes in thedetails, materials, steps and arrangements of parts, which have beenherein described and illustrated in order to explain the nature of thepresent invention, may be made by those skilled in the art while stillremaining within the principles and scope of the invention.

The invention claimed is:
 1. A method for confirming integrity of asterilization container, the method comprising: closing a sterilizationcontainer having at least one vented area that allows fluids to passinto and out of the sterilization container where the at least onevented area is located in a wall of the sterilization container;positioning a first filter to fully cover the at least one vented areaand such that the first filter extends beyond a perimeter of the atleast one vented area; engaging a frame member against the sterilizationcontainer and adjacent to the first filter; positioning a second filterover the first filter such that the second filter covers the at leastone vented area; affixing an edge of a filter cover against thesterilization container to engage the second filter directly against thefirst filter and the first filter against the wall such that the edge ofthe filter cover seals both the first filter and the second filteragainst the sterilization container; initiating a sterilization cycle onthe sterilization container; disengaging the edge of the filter coverfrom the second filter and the sterilization container; removing thesecond filter from the first filter without removing the first filterfrom the at least one vented area; and examining the second filter toassess an integrity of the first filter.
 2. The method of claim 1,further comprises engaging a portion of the first filter to the wall ofthe sterilization container by securing the first filter between thewall of the sterilization container and the frame member, where theframe member is secured to the wall.
 3. The method of claim 2, where theframe member is detachably secured to the wall.
 4. The method of claim2, where the frame member is moveable secured to the wall.
 5. The methodof claim 4, further comprising a hinge moveably securing the framemember to the wall.
 6. The method of claim 2, where the frame membercomprises a ring shape.
 7. The method of claim 2, where the frame membercomprises a material selected from a group consisting of a metal, apolymer, a composite material.
 8. The method of claim 2, where the framemember is disposable.
 9. The method of claim 8, further comprising usinga transfer cart to relocate the sterilization container.
 10. The methodof claim 8, further comprising using a transfer cart to relocate thesterilization container to a second transportation vehicle.
 11. Themethod of claim 2, where the frame member is reusable.
 12. The method ofclaim 2, where the edge of the filter cover is positioned within aperimeter of the frame member.
 13. The method of claim 1, where closingthe sterilization container comprises loading at least one surgical traycontaining a surgical instruments into an interior of sterilizationcontainer prior to closing the sterilization container.
 14. The methodof claim 1, further comprising relocating the sterilization containerfrom a sterile location after examining the second filter to assess theintegrity of the first filter without removing the first filter from thesterilization container.